It is last weeks news that FDA’s leadership turnover has been the highest in memory, possibly ever.
What should concern everyone is the response of industry to this degree of uncertainty at FDA.
Drug company Regenxbio last week reported compelling phase 2 data for its Duchenne muscular dystrophy gene therapy, but is electing to hold off on approaching the FDA until the “dust settles.”
At this point, what does “dust settling” even look like?
I have no doubts the folks named to serve at the highest levels over the past week in an acting capacity have the health and safety of the American people first and foremost in mind. These acting roles include the FDA commissioner (Kyle Diamantas, JD), director of Center for Drug Evaluation and Research or CDER (Michael Davis, MD, PhD), director of Center for Biologics Evaluation and Research or CBER (Karim Mikhail, MSc) and the Human Foods Program (Donald Prater, DVM).
But what signal can these interim commissioners and directors send to industry that it is appropriate to proceed (or initiate) discussions with FDA?
These aren’t small matters, as the health of our nation depends on a vibrant ecosystem of medical technologies and therapies being regulated by a stable and quantifiable FDA.
But the FDA can’t regulate new products if companies aren’t confident in even talking with them.
I get that the tobacco industry felt treated unfairly by former FDA commissioner Dr. Markary’s refusal to sign off on new nicotine approvals, which led to his ouster, and since then it appears that that pipeline for nicotine product approvals is opening.
But now we have a perception of severe disarray at FDA by the drug and biologics industry, to the degree that companies don’t want to discuss products until a point to be determined in the future. I can’t imagine Regenxbio is alone in this opinion, they just publicly pointed at the elephant in the room.
I don’t know how sufficient stability would be signaled to both industry and investors in pharmaceutical products.
Possibly confidence could be conferred by new policies and/or approvals being received enthusiastically by industry, but it is difficult to say this would work with any degree of confidence.
While I have to remain optimistic, I can’t see a great deal of clarity for industry until a new FDA commissioner is selected by the current administration and confirmed by the Senate.
Senate confirmation takes time, even under the best of circumstances.
Instead we are in an incredibly fractious point in time, with a major election less than 6 months out. Unless there is a good faith effort to find a candidate that is embraced by both sides of the aisle, it is hard to imagine a new FDA commissioner being confirmed soon, if this year at all.
Meanwhile, pharmaceutical development slows (and possibly device development if caught up in the blast radius), potentially significantly, while this all gets sorted out.
So where are we currently with the hunt for a new FDA commissioner? According to Trump “Everyone wants that job,” so it should be easy, right?
It turns out not everyone wants that job, including those who have served as FDA Commissioner in a confirmed or acting capacity, as well those serving in other high ranking positions. Stephen Hahn, MD, who was FDA Commissioner from late 2019 to 2020 and on the short list of potential candidates, announced he is taking the executive clinical and regulatory lead role at Turn Therapeutics. Brett Giroir, MD, who was acting FDA Commissioner in 2019 (preceding the confirmation of Stephen Hahn), said on Linkedin “I am not a candidate for the role at this time,” as he was committed to addressing family health challenges and his increasing role at OncoNano Medicine. Richard Padzur, MD, who was Director of the FDA Oncology Center of Excellence from 1999-2025, has “sidestepped calls” that he put his name up as a candidate.
The current acting FDA commissioner, Kyle Diamantas, could be a candidate that Trump names for confirmation. However, it was reported yesterday that he called anti-abortion leaders on his first full day in office and said he would be convening a group of scientists and clinical reviewers to assess the status of a promised-but-delayed safety study on mifepristone, the abortion drug the anti-abortion movement is seeking to ban.
It is worth noting this promised-but-delayed safety study on mifepristone was related to Makary’s ouster, in addition to the tobacco industry requests. This is passing no judgments on Kyle Diamantas or his actions, but the political reality is any FDA commissioner candidate who is proposing a safety study on mifepristone will almost certainly receive a wall of Senate no votes from all 47 Democratic Senators.
And as of this week there are increasing signs of discontent from Republican senators. This includes those who have chosen not to run again (Thom Tillis of North Carolina), those who have been primaried by Trump for not being supportive enough of Trump (Bill Cassidy of Louisiana and a physician) or have a high probability to be primaried by Trump (John Cornyn of Texas). Lisa Murkowski of Alaska and Susan Collins of Maine both are not reliable supporters of Trump and typically vote pro-choice. Other Republican Senators are incensed that Trump has strove to primary Cassidy (successfully) and Cornyn (possibly) and may prove less than supportive.
Taken together, this is not supportive of the simple majority math needed to confirm Kyle Diamantas.
Ned Sharpless, MD, who was acting FDA Commissioner from April 5 to Nov. 1, 2019 and director of the National Cancer Institute from 2017 to 2022 (except for the months he was leading FDA), has been named a potential candidate. At the moment, there is no update on his willingness to take on role.
This is obviously an evolving story. It is high priority interest to those in industry who deal with FDA for regulated products (drugs, vaccines, medical devices including those that may incorporate AI, food, veterinary products and tobacco), those who are marketing products that are not regulated by FDA (supplements, clinical decision support and wellness products that may incorporate AI), as well as those trying to figure out if their product is regulated by FDA (cannabis and CBD) and how it will be regulated. But it is also critically important to the health of users of such products and the health care professionals that treat their patients.
